- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07850596
Quadratus Lumborum Block, Transversus Abdominis Plane Block, and Erector Spinae Block in Pediatric Abdominal Surgery
Comparing Quadratus Lumborum Block, Transversus Abdominis Plane Block, and Erector Spinae Block in Pediatric Abdominal Surgery
The aim of this study is to compare the analgesic efficacy and safety of Quadratus Lumborum (QL), Transversus Abdominis Plane (TAP), and Erector Spinae Plane (ESP) blocks in pediatric abdominal surgery.
Study Overview
Status
Conditions
Detailed Description
Advances in perioperative care of children continue to be made with increasing evidence-based practice for postoperative analgesia. However, moderate to severe pain is still experienced by up to 40% of hospitalized children and specific high-risk populations or types of surgery continue to present challenges.
Transversus abdominis plane (TAP) block involves the injection of local anesthesia (LA) in between the transversus abdominis (TA) and internal oblique (IO) muscles.
The Erector Spinae Plane (ESP) block is most often performed using an in-plane ultrasound-guided technique. It is a paraspinal fascial plane block in which the needle placement is between the erector spinae muscle and the thoracic transverse processes, and a local anesthetic is administered, blocking the dorsal and ventral rami of the thoracic and abdominal spinal nerves.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Menoufia
-
Shibīn al Kawm, Menoufia, Egypt, 32951
- Menoufia University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children aged from 3 to12 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) Physical Status I-II.
- Scheduled for pediatric abdominal surgery.
Exclusion Criteria:
- Allergy or contraindication to bupivacaine or dexmedetomidine.
- Coagulopathy.
- Local infection at the site of the block.
- Neurological or psychiatric disorders affecting pain perception.
- Refusal of the regional technique by parents/guardians.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: QL Group
Patients received quadratus lumborum (QL) block with bupivacaine 0.25% (0.5 ml/kg) + dexmedetomidine 0.5 mcg/kg. |
Patients received quadratus lumborum (QL) block with bupivacaine 0.25% (0.5 ml/kg) + dexmedetomidine 0.5 mcg/kg.
Other Names:
|
|
Experimental: TAP group
Patients received transversus abdominis plane (TAP) block with bupivacaine 0.25% (0.5 ml/kg) + dexmedetomidine 0.5 mcg/kg |
Patients received transversus abdominis plane (TAP) block with bupivacaine 0.25% (0.5 ml/kg) + dexmedetomidine 0.5 mcg/kg.
Other Names:
|
|
Experimental: ES Group
Patients received erector spinae plane (ESP) block with bupivacaine 0.25% (0.5 ml/kg) + dexmedetomidine 0.5 mcg/kg. |
Patients received erector spinae plane (ESP) block with bupivacaine 0.25% (0.5 ml/kg) + dexmedetomidine 0.5 mcg/kg.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Degree of pain
Time Frame: 24 hours postoperatively
|
Degree of pain will be assessed using Wong-Baker FACES for the first 24 hours postoperative at 4, 8,12,16 and 24 hours postoperatively. Wong-Baker FACES Pain Scale, which utilizes a series of 6 faces increasing in pain severity may be used to facilitate communication and assist in pain assessment . |
24 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total fentanyl consumption
Time Frame: Intraoperatively
|
If patient require analgesia during surgery (diagnosed by increasing heart rate and blood pressure) fentanyl 1mic/kg will be given, and total analgesic consumption will be calculated and recorded. |
Intraoperatively
|
|
Heart rate
Time Frame: Till the end of surgery (Up to 2 hours)
|
Heart rate will be recorded every 15 minutes till the end of surgery. |
Till the end of surgery (Up to 2 hours)
|
|
Mean arterial blood pressure
Time Frame: Till the end of surgery (Up to 2 hours)
|
Mean arterial blood pressure will be recorded every 15 minutes till the end of surgery. |
Till the end of surgery (Up to 2 hours)
|
|
Time of each block
Time Frame: Intraoperatively
|
Time of each block will be recorded from using ultrasound probe till injection of local anaesthetic |
Intraoperatively
|
|
Sedation score
Time Frame: 24 hours postoperatively
|
Sedation score will be recorded at 0, 15 min ,30 min postoperative 0=no sedation (wide awake). =slightly sedated (easy to arouse) 2=moderately sedated(easy to arouse but cannot stay awake) 3=heavy sedated (difficult to arouse) |
24 hours postoperatively
|
|
Time to first rescue analgesia
Time Frame: 24 hours postoperatively
|
Time to first rescue analgesia will be recorded from the end of surgery till first dose of morphine administrated. |
24 hours postoperatively
|
|
Total morphine consumption
Time Frame: 24 hours postoperatively
|
If the pain score more than or equal to 4), opioid (morphine) 0.5 to 1 mg/kg will be given and total dose will be calculated |
24 hours postoperatively
|
|
Incidence of postoperative complications
Time Frame: 24 hours postoperatively
|
Incidence of postoperative complications such as hypotension, nausea and vomiting will be recorded. |
24 hours postoperatively
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Organic Chemicals
- Heterocyclic Compounds, 1-Ring
- Heterocyclic Compounds
- Azoles
- Imidazoles
- Anilides
- Amides
- Aniline Compounds
- Amines
- Behavioral Disciplines and Activities
- Digestive System and Oral Physiological Phenomena
- Behavioral Sciences
- Dentistry
- Dental Physiological Phenomena
- Bupivacaine
- Dexmedetomidine
- Dental Occlusion
- Parapsychology
Other Study ID Numbers
- 12/2024 ANET 32
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
IPD Sharing Time Frame
After the end of study for one year.
IPD Sharing Access Criteria
The data will be available upon a reasonable request from the corresponding author.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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